FDA 483 - Shanghai Henlius Biologics Co., Ltd. Songjiang Site 2 - March 11, 2025

The FDA inspected Shanghai Henlius Biologics Co., Ltd. Songjiang Site 2, a drug product manufacturer, and identified significant deficiencies. The inspection revealed inadequate process controls for sterility and product quality, inconsistent aseptic filling operations, and a lack of proper procedures to prevent microbiological contamination. Additionally, the firm's Quality Unit oversight was found to be insufficient, indicating a high risk to drug product quality and patient safety.